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You are here: Home / Uncategorized / Ethical issues in the conduct of clinical trials in obstructive sleep apnea

Ethical issues in the conduct of clinical trials in obstructive sleep apnea

March 18, 2011 by Randy Clare Leave a Comment

Abstract

Scientifically rigorous clinical trials are needed to test continuous positive airway pressure’s (CPAP) effect on important clinical endpoints known to be associated with obstructive sleep apnea, such as myocardial infarction, cardiac arrhythmias, stroke, mortality, seizures, and cognitive function. In this “Special Article,” we review the regulatory and ethical issues that surround the design and conduct of CPAP trials, including selection of the appropriate control condition, exclusion criteria, and follow-up duration. CITATION: Brown DL; Anderson CS; Chervin RD; Kushida CA; Lewin DS; Malow BA; Redline S; Goldman EB. Ethical issues in the conduct of clinical trials in obstructive sleep apnea. J Clin Sleep Med 2011;7(1):103-108.

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Randy Clare
Managing Editor of SleepScholar and RespiratoryScholar
Dr. Steve Carstensen
Pankey Institute for Advanced Dental Education, American Academy of Dental Sleep Medicine.
Ruchir Patel MD
Founder & Medical Director at the Insomnia and Sleep Institute of Arizona.
Dr. John S. Viviano
AADSM Diplomate and member of various sleep organizations. Has lectured internationally on the treatment of Sleep-Disordered Breathing and the use of Acoustic Reflection.
Jeffroy Wyscarver
President, DDME Online, Sleep Lab Technology and Services for the Dental Community.
Claude Albertario
RPSGT, speaker, author and mentor in the field of sleep diagnostics with 25 yrs of management experience in one of New York's premier sleep centers.
Joseph Anderson
Co-Founder and Director of Education for Priority Health Education and Priority Scoring.
Todd Austin
Managed sleep labs and has 15 experience in sleep diagnostics and therapeutic systems. .
Marietta Bibbs
Sleep specialist and manager of Sleep and Neurodiagnostics at Morton Plant Mease Healthcare.
Bradley Eli DMD, MS
Director, San Diego Headache and Facial Pain Center / Sleep Treatment and Research Institute
Edward Grandi
Executive Director of the American Sleep Apnea Association.
Edward Michaelson MD
Board Certified in Pulmonary Medicine, Internal Medicine and Sleep Medicine
Ashley Truitt
Founder & Director of Dental Sleep Medicine Worldwide, Co-Founder of TPT Dental.

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